Influence of Atorvastatin on Psoriasis Severity and Endothelial Function

Psoriasis Clinical Trial

Official title:

Atorvastatin to Reduce Psoriasis Severity and Improve Endothelial Function in Patients With Severe Psoriasis and Non-Elevated LDL Levels: A Randomized, Double Blind, Placebo-Controlled Study.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01527097
• Other study ID #: 0263 - 11 - RMC
• Status: Withdrawn
• Phase: Phase 3
• First received: January 15, 2012
• Last updated: November 16, 2015
• Start date: August 2012
• Est. completion date: April 2015

Study information

• Verified date: November 2015
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Patients with psoriasis seem to have increased risk for developing atherosclerosis. This may be due to the fact that psoriasis and atherosclerosis are both caused by inflammation and involvement of cells of the immune system. Atherosclerosis is frequently treated by statins (class of cholesterol lowering drugs), which lower bad cholesterol levels and also reduce inflammation. Some new evidences also suggest that therapy with statins may improve psoriasis skin disease.

The current study aims are to evaluate whether a strong statin named Atorvastatin can improve psoriatic skin disease and functioning of the arteries. The study also aims to evaluate if the activity of these two diseases are related to levels of common inflammatory biomarkers (substance in blood) and whether Atorvastatin can change their levels.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 20 years

• Patients with psoriasis of at least 3-years duration

• Current moderate to severe psoriatic disease (PASI =12, IGA=3)

• Statin-naïve patients

• No history of cardiovascular disease (ischemic heart disease, peripheral vascular disease or cerebrovascular disease)

• LDL levels

• LDL level > 70 mg% and < 160 mg% in low risk patients (defined as having none or a single risk factor*)

• LDL > 70 mg% and < 130 mg% in moderate risk patients (defined as the presence of 2 or more risk factors*)

• LDL > 70 mg% and < 100 mg% in patients with type II diabetes

• hsCRP = 1 mg/l * Risk factors: smoking, hypertension (blood pressure > 140/90 or current treatment with blood pressure lowering agents, HDL < 40 mg%, family history of premature coronary artery disease in a first degree relative younger than 45 (men) or 55 (women) and obesity (BMI = 30).

Exclusion Criteria:

• Current statin therapy

• Patents with Atrial Fibrillation

• Elevated liver enzymes (> X3 ULN)

• History of statin-induced liver enzyme elevation

• Elevated CPK levels (> X3 ULN)

• History of myopathy including statin-induced

• Severe chronic renal failure (GFR <30 ml/min)

• Pregnant or breast-feeding women

• Individuals at risk for poor protocol, or medication compliance

• Patients with life-expectancy of less than 2 years

• Patients who are currently participating in another clinical trial

• Other current active inflammatory and/or infectious conditions

• Sensitivity to any of atorvastatin ingredients

• Concomitant drug therapy, taken on a regular basis, which may interact with Atorvastatin

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Atorvastatin
Drug: Atorvastatin 80 mg for 6 months following by 40 mg for additional 6 months once daily.
• Atorvastatin placebo
Atorvastatin 80mg during 6 month and 40mg in additional 6 month period once daily.

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Beilinson Hospital	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
shmuel fuchs

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy outcome variable of the study is defined as the composite endpoint of improving of psoriatic severity and endothelial function (assessed by FMD changes).	Patient invited to clinic visits at 3,6 and 12 month follow up.At this visits in addition primary outcome will be measured.	3,6 and 12 months after randomization.	No